NCT04830397

Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).

A Randomized Active-controlled Multi-site Double-masked Study to Evaluate the Safety and Tolerability of 3 Concentrations of QLS-101 Versus Timolol Maleate Preservative Free (PF) 0.5% Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Qlaris Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.

Detailed description

Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	QLS-101	Ophthalmic solution 1x daily
DRUG	Timolol Maleate	Ophthalmic solution 1x daily

Timeline

• Start date: 2021-03-31
• Primary completion: 2022-02-17
• Completion: 2022-02-17
• First posted: 2021-04-05
• Last updated: 2025-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study